Bio-logic receives 510K to market new ambulatory polysomnography system.MUNDELEIN, Ill.--(BUSINESS WIRE)--Aug. 28, 1996--Bio-logic Systems Corp. (Nasdaq: BLSC) ("Bio-logic" or the "Company"), a designer and marketer of computerized medical electrodiagnostic equipment, today announced that it has received FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. permission to market its new Sleepscan(TM) Traveler(R) Ambulatory Polysomnography System. The Sleepscan Traveler is a miniaturized computer which records physiological activity used in the diagnosis of sleep disorders such as sleep apnea (breathing cessation). The company currently markets both a desktop and portable system to hospitals and sleep labs worldwide. However, the Sleepscan Traveler is designed to meet the space limitations, durability and simplicity requirements of in-home sleep studies. The system weighs approximately two pounds and is encased in a shock-resistant plastic body with no moving external parts or buttons making it nearly patient-proof. Additionally, its compactness allows the hospital greater flexibility to perform sleep studies in any patient room which eliminates the wait for an available bed in the sleep lab. "The Sleepscan Traveler is the second in a series of products which will incorporate miniaturization, capitalization of computer industry innovation and our commitment to develop diagnostic systems which meet the needs of the growing ambulatory marketplace," said Dr. Gabriel Raviv, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Bio-logic Systems Corp. "This product was conceived at the time we were developing the Ceegraph Traveler (ambulatory electroencephalography electroencephalography (əlĕk'trōĕnsĕf'əlŏg`rafē), science of recording and analyzing the electrical activity of the brain. system which received 510K approval last year) so we've been able to utilize most of the same components to greatly reduce our development costs," Raviv said. The company will market three models: 8, 19 and up to 27 channels (for combining epilepsy and sleep diagnostics). The battery operated unit measures oximetry oximetry /ox·im·e·try/ (ok-sim´e-tre) determination of the oxygen saturation of arterial blood using an oximeter. oximetry (oksim´itrē), n , heart rate, body position, air flow, EEG EEG: see electroencephalography. , EKG EKG: see electrocardiography. and EMG EMG abbr. electromyogram Electromyography (EMG) A diagnostic test that records the electrical activity of muscles. and is priced from $10,000 to $20,000. Unique features include a built-in oximeter oximeter /ox·im·e·ter/ (ok-sim´e-ter) a photoelectric device for determining the oxygen saturation of the blood. ox·im·e·ter n. Pulse oximeter. , data analysis using the Sleepscan Analysis Software, and Bio-logic's exclusive Smart-Pack(TM) data compression which extends the disk storage by more than two and a half times. The company expects to be able to deliver to customers within three months. Prospective investors are cautioned that the statements in this press release which are not descriptions of historical facts, may be forward looking statements that are subject to risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors. CONTACT: Bio-logic Systems Corp., Mundelein Gabriel Raviv, President and CEO, 847/949-5200 |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion